US4559950A - Disposable biomedical and diagnostic electrode - Google Patents
Disposable biomedical and diagnostic electrode Download PDFInfo
- Publication number
- US4559950A US4559950A US06/555,071 US55507183A US4559950A US 4559950 A US4559950 A US 4559950A US 55507183 A US55507183 A US 55507183A US 4559950 A US4559950 A US 4559950A
- Authority
- US
- United States
- Prior art keywords
- conductive
- set forth
- electrode
- gel
- adhesive composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/251—Means for maintaining electrode contact with the body
- A61B5/256—Wearable electrodes, e.g. having straps or bands
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/251—Means for maintaining electrode contact with the body
- A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
Definitions
- This invention relates to single-use, disposable biomedical and diagnostic electrodes of the type used to detect biological or physiological electrical potentials. Such potentials have long been recognized as being derived from or associated with muscular activity.
- the electrode of the subject invention is characterized by improved electrical contact with the skin to which it is applied, thereby to establish and maintain a desirable low impedance value and to minimize motion artifacts or electrical noise, without the need for gels, except in special cases.
- ECG electrodes of the disposable type are pregelled, the gel itself being contained in a cavity which is often filled with a porous, gel-retaining sponge-like element. While many improvements have been made in various facets of disposable electrodes in recent years, the products available still harbor objectionable features and fall short of fully satisfying the demanding technical requirements and the need for consistently reliable performance. It is, therefore, a principal aim of the present invention to provide an improved disposable electrode which obviates many of the shortcomings of the prior art devices and provides an improved single-use electrode which is of low cost in production so as to be conveniently and economically disposable and which, at the same time, satisfies the demanding standards of function and reliability.
- the present invention relates to a biomedical electrode with improved means for effective electric contact between the electrode and a body surface ensuring high fidelity signal transduction, negligible electrical drift, a minimization of polarization and distortion, and an avoidance of artifacts or noise in the recordings or records produced during use of the electrode.
- the electrode is particularly suitable for detecting and monitoring low-level electrical signals, the reliability being enhanced by an improved mode of securement of the electrode in place, and by improved electrical contact effected between the electrode itself and the skin surface.
- An additional important feature of the improved electrode structure of the invention is that conductive skin contact is selectively enhanced, when necessary, by application of a conductive gel, the latter being contained in and releasable from a storage cavity in the electrode itself.
- a related feature of the electrode of the invention is that there is provided a pressure releasable gel which establishes a fluid film interface bridging between the patient's skin and the conductive adhesive and, concurrently, provides a highly conductive path between the electrode lead line and the patient's skin.
- the gel serves as a stabilizing factor for the adhesive by serving as a humidifier for the adhesive.
- a general feature of the invention is that the electrode functions without a gel. Yet a gel is available, at hand, for use in enhancing electrical contact with the patient's skin when such enhancement is found necessary.
- the electrode is formed to define a storage cavity constituting a reservoir for a gel composition.
- a selectably actuable port communicating between the gel reservoir and the patient's skin is defined by a pre-cut slit in the skin-presented support band of the electrode.
- a related feature of the invention is that the pre-cut slit in the support band defines an orifice which is in a normally closed or standby mode.
- the support band is responsive to fluid pressure applied thereagainst to open the slit and to promote gel flow or passage therethrough, from the reservoir cavity, thereby to provide an enhanced electrically conductive path between the conductor lead line of the electrode and an electrode-delineated body zone to which the electrode is adhered.
- the conductivity of the conductive adhesive is enhanced through the incorporation of electrically conductive particles distributed throughout the adhesive composition.
- a principal feature of a preferred embodiment of the electrode of the invention is the use of a conductive adhesive which, in a preferred embodiment of the invention, includes salts dispersed therethrough for rendering the adhesive ionically conductive.
- a related feature of the conductive adhesive of the invention is that conductive particles contained therein and distributed therethrough constitute carbon particles.
- the conductivity properties are enhanced through the incorporation of metallic particles, and in an alternative embodiment, electrical conductivity of the conductive adhesive is enhanced through the incorporation of conductively coated glass spheres or other inert particles.
- the optional release and use of the conductive gel is effected at the time the electrode is adhesively bonded to the skin surface.
- FIG. 1 is a top plan view of an electrode according to the invention, incorporating the features thereof;
- FIG. 2 is a cross sectional view taken substantially on the lines 2--2 of FIG. 1;
- FIG. 3 is an expanded view showing the relative arrangement of the various stacked components of the electrode of the invention.
- FIG. 4 is an exploded perspective showing the component elements of the electrode of the invention.
- FIG. 5 is a cross-sectional view of an alternative form of an element of the electrode structure of the invention.
- the aims and objects of the invention are achieved by providing in a disposable biomedical and diagnostic electrode conductive adhesive electrical contact and an optionally usable gel reservoir. Electrical connection and continuity are achieved by means of a conductive adhesive which constitutes a bonding interface interposed between an undersurface of the electrode and the body zone to which the electrode is applied in use.
- the conductive adhesive is in electrically conductive contact with a conductive element of the electrode to which a lead line may be attached.
- the electrode of the invention is further characterized in that there is provided a conductive gel reservoir, and in that a selectively actuable port defines passage means communicating between the gel storage reservoir or cavity and the conductive adhesive surface and the skin zone to which the electrode is adhered.
- finger pressure selectively transmitted to the gel contained in the reservoir forces the gel through the port and establishes a film interface between the patient's skin and the conductive adhesive and, concurrently, provides an enhanced conductive path between the electrode itself and the patient's skin.
- the single-use disposable electrode consists of a multi-layer, mult-component structure supported on a peelable release liner 24.
- the release liner 24 may be a silicone-treated sheet of paper, a plastic film, or other type of release liner as known in the art.
- a conductive strip 28 with a conductive adhesive 32 applied to its under surface is releasably adhered to the release liner 24.
- the conductive strip 28 may be a strip of metal or of other selectable conductive materials.
- the conductive strip 28 comprises a conductive chemical composition 30 applied to a flexible plastic support band or ribbon 29, as shown in FIG. 3.
- the support band 29 may be a sheet of MYLAR polyester, for example, while the conductive chemical composition 30 may be a metallic ink such as a silver ink.
- the surface of the conductive chemical composition 30 may be chloridized as known in the art in order to improve the electrochemical reversibility of the electrode 20.
- a snap fastener stud 38 and eyelet 40 for the convenient snap-on attachment of a lead line (not shown) during electrode use.
- a lead line may be secured through other expedients, for example, by attachment of a clamping clip to the projecting end portion 36 of the strip 28.
- a tab 42 of plastic or similar non-conductive material is secured on the undersurface of the strip 28 to project beyond the end of the strip 28 and to serve as an insulating shield between the electrical clip (not shown) and the patient's body.
- the electrically conductive strip 28 is provided with a die-cut slit 46 which in an undisturbed state is essentially "closed".
- the slit 46 illustrated schematically, is best seen in the exploded perspective of FIG. 4. Holes may be substituted for the slit.
- a cushion-like wafer or washer-like disk 50 of a relatively soft and compressible, inert foamed plastic Superimposed on and bonded to and overlying the strip 28 is a cushion-like wafer or washer-like disk 50 of a relatively soft and compressible, inert foamed plastic.
- the disk 50 is formed with a circular cut-out area 52 and, in the positioning of the disk 50 with respect to the strip 28, an in-line axial registration is established between the cut-out area 52 of the disk 50 and the slit 46 in the strip 28 therebelow (FIG. 2). It will be appreciated that in the structure described, there is provided a cavity which is defined by the cut-out 52 in the disk 50 and which is closed at its base by the strip 28.
- the open-top cavity is filled with a conductive gel 60.
- a conductive gel 60 Many suitable conductive gel compositions are known in the art, and the specific composition of the gel itself is not critical in the practice of the present invention.
- the gel should contain a substantial concentration of a humectant, for example, at least about 50% by weight of glycerol.
- the underface of the disk to is coated with an adhesive composition 62 so that, in assembly, the disk 50 is secured not only to the strip 28 but also to the peelable release liner 24 therebelow and extending laterally thereabout.
- the open top of the cavity 52 is closed or sealed by means of a plastic cover 64 which is coated on its underside with an adhesive 66, so that the closure 64 is securely bonded and sealed to the top surface 70 of the foam washer 50.
- the electrode 20 assumes the structure illustrated schematically in FIG. 2.
- the electrode is applied to the selected skin surface zone by a conventional procedure.
- the conductive surface may be established by applying a metal-containing ink formulation.
- a metal-containing ink formulation various formulations of conductive adhesives may be used in the practice of the present invention. None of these formulations constitutes, per se, an element of the present invention.
- the principal mode of electrical transmission through the conductive adhesive will be by ions rather than by electrons, and the thickness of the conductive adhesive layer 32 will be small, preferably less than 10 mils. Ionic conductivity provides superior electrochemical reversibility and hence superior signal transmission fidelity in a biomedical electrode, while thinness of the conductive adhesive layer allows the conductive adhesive layer to conform to the skin, thus maintaining uniform electrical properties.
- Such adhesives may be enhanced through the incorporation of fillers including salts or electrically conductive particles.
- Such particles may be metallic particles, or, alternatively, carbon particles, or other inert particles, or glass coated with suitable conductive materials. While preferred embodiments of the invention have been illustrated, other variations may be made utilizing the inventive concepts herein disclosed. It is intended that all such variations in functional structures and in compositions be considered as within the scope of the invention as defined in the following claims.
Abstract
Description
Claims (19)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US06/555,071 US4559950A (en) | 1983-11-25 | 1983-11-25 | Disposable biomedical and diagnostic electrode |
US06/673,552 US4588762A (en) | 1983-11-25 | 1984-11-20 | Pressure sensitive adhesive compositions for medical electrodes |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US06/555,071 US4559950A (en) | 1983-11-25 | 1983-11-25 | Disposable biomedical and diagnostic electrode |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US06/673,552 Continuation-In-Part US4588762A (en) | 1983-11-25 | 1984-11-20 | Pressure sensitive adhesive compositions for medical electrodes |
Publications (1)
Publication Number | Publication Date |
---|---|
US4559950A true US4559950A (en) | 1985-12-24 |
Family
ID=24215850
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US06/555,071 Expired - Fee Related US4559950A (en) | 1983-11-25 | 1983-11-25 | Disposable biomedical and diagnostic electrode |
Country Status (1)
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US (1) | US4559950A (en) |
Cited By (75)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0284943A1 (en) * | 1987-03-30 | 1988-10-05 | Fukuda Denshi Co., Ltd. | Multi-electrode type electrocardiographic electrode structure |
US5150708A (en) * | 1990-12-03 | 1992-09-29 | Spacelabs, Inc. | Tabbed defibrillator electrode pad |
US5402780A (en) * | 1993-09-02 | 1995-04-04 | Faasse, Jr.; Adrian L. | Medical electrode with offset contact stud |
US5458141A (en) * | 1993-08-04 | 1995-10-17 | Quinton Instrument Company | Abrasive skin electrode |
US5566672A (en) * | 1994-01-03 | 1996-10-22 | Labeltape Meditect, Inc. | Biomedical electrode |
US5645063A (en) * | 1995-06-05 | 1997-07-08 | Quinton Instrument Company | Skin electrode having multiple conductive center members |
WO2000002484A1 (en) * | 1998-07-10 | 2000-01-20 | Physiometrix, Inc. | Self adjusting headgear appliance using reservoir electrodes |
EP1078595A3 (en) * | 1999-08-24 | 2001-03-07 | Cas Medical Systems, Inc. | Disposable neonatal electrode for use in a high humidity enviroment |
US6301493B1 (en) * | 1999-07-10 | 2001-10-09 | Physiometrix, Inc. | Reservoir electrodes for electroencephalograph headgear appliance |
US6526303B1 (en) * | 2000-10-27 | 2003-02-25 | Koninklijke Philips Electronics N.V. | Disposable defibrillation and external pacing electrode |
US20040162602A1 (en) * | 2003-02-19 | 2004-08-19 | Shlomi Cohen | Surface electrode for electrical stimulation of tissue |
US20040249432A1 (en) * | 2003-02-19 | 2004-12-09 | Stimu-Heal Inc. | Surface electrode for electrical stimulation of tissue |
US7069074B2 (en) | 2001-11-07 | 2006-06-27 | Medtronic Emergency Response Systems, Inc. | Easy-to-use electrode and package |
US20060155181A1 (en) * | 2002-08-21 | 2006-07-13 | Ruediger Eichler | Measuring electrode system |
US7978064B2 (en) | 2005-04-28 | 2011-07-12 | Proteus Biomedical, Inc. | Communication system with partial power source |
US8036748B2 (en) | 2008-11-13 | 2011-10-11 | Proteus Biomedical, Inc. | Ingestible therapy activator system and method |
US8054140B2 (en) | 2006-10-17 | 2011-11-08 | Proteus Biomedical, Inc. | Low voltage oscillator for medical devices |
US8055334B2 (en) | 2008-12-11 | 2011-11-08 | Proteus Biomedical, Inc. | Evaluation of gastrointestinal function using portable electroviscerography systems and methods of using the same |
US8114021B2 (en) | 2008-12-15 | 2012-02-14 | Proteus Biomedical, Inc. | Body-associated receiver and method |
US8115618B2 (en) | 2007-05-24 | 2012-02-14 | Proteus Biomedical, Inc. | RFID antenna for in-body device |
US8258962B2 (en) | 2008-03-05 | 2012-09-04 | Proteus Biomedical, Inc. | Multi-mode communication ingestible event markers and systems, and methods of using the same |
US20120265025A1 (en) * | 2011-04-13 | 2012-10-18 | King's Metal Fiber Technologies Co., Ltd. | Wearing structure for measuring physiological signal |
WO2012140629A1 (en) * | 2011-04-15 | 2012-10-18 | Universidade Do Porto | Polymer-based electrode for bio-signal recording |
US20130023748A1 (en) * | 2011-07-11 | 2013-01-24 | Nellcor Puritan Bennett Llc | Device with encapsulated gel |
US8540633B2 (en) | 2008-08-13 | 2013-09-24 | Proteus Digital Health, Inc. | Identifier circuits for generating unique identifiable indicators and techniques for producing same |
US8540664B2 (en) | 2009-03-25 | 2013-09-24 | Proteus Digital Health, Inc. | Probablistic pharmacokinetic and pharmacodynamic modeling |
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US8545402B2 (en) | 2009-04-28 | 2013-10-01 | Proteus Digital Health, Inc. | Highly reliable ingestible event markers and methods for using the same |
US8558563B2 (en) | 2009-08-21 | 2013-10-15 | Proteus Digital Health, Inc. | Apparatus and method for measuring biochemical parameters |
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Cited By (138)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0284943A1 (en) * | 1987-03-30 | 1988-10-05 | Fukuda Denshi Co., Ltd. | Multi-electrode type electrocardiographic electrode structure |
US5150708A (en) * | 1990-12-03 | 1992-09-29 | Spacelabs, Inc. | Tabbed defibrillator electrode pad |
US5458141A (en) * | 1993-08-04 | 1995-10-17 | Quinton Instrument Company | Abrasive skin electrode |
US5402780A (en) * | 1993-09-02 | 1995-04-04 | Faasse, Jr.; Adrian L. | Medical electrode with offset contact stud |
US5566672A (en) * | 1994-01-03 | 1996-10-22 | Labeltape Meditect, Inc. | Biomedical electrode |
US5645063A (en) * | 1995-06-05 | 1997-07-08 | Quinton Instrument Company | Skin electrode having multiple conductive center members |
WO2000002484A1 (en) * | 1998-07-10 | 2000-01-20 | Physiometrix, Inc. | Self adjusting headgear appliance using reservoir electrodes |
US6301493B1 (en) * | 1999-07-10 | 2001-10-09 | Physiometrix, Inc. | Reservoir electrodes for electroencephalograph headgear appliance |
US6687524B1 (en) | 1999-08-24 | 2004-02-03 | Cas Medical Systems, Inc | Disposable neonatal electrode for use in a high humidity environment |
EP1078595A3 (en) * | 1999-08-24 | 2001-03-07 | Cas Medical Systems, Inc. | Disposable neonatal electrode for use in a high humidity enviroment |
US6526303B1 (en) * | 2000-10-27 | 2003-02-25 | Koninklijke Philips Electronics N.V. | Disposable defibrillation and external pacing electrode |
US20060206152A1 (en) * | 2001-10-02 | 2006-09-14 | Medtronic Emergency Response Systems, Inc. | Easy-to-use electrode and package |
US20100063558A9 (en) * | 2001-10-02 | 2010-03-11 | Medtronic Emergency Response Systems, Inc. | Easy-to-use electrode and package |
US7797044B2 (en) | 2001-10-02 | 2010-09-14 | Physio-Control, Inc. | Easy-to-use electrode and package |
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